In the pharmaceutical product manufacturing industry, drugs including source materials and pharmaceutical preparations are manufactured via various unit operations such as mixing, reacting, extracting, filtering, and purifying, using an isolator or a stainless steel tank for sterile formulation under a clean environment. When one unit operation is transitioning to the next unit operation, raw materials treated in such unit operations are transferred by being translocated to a connected line or a transfer container. Such transfer may be performed from a drug preparation section to a filling operation section within a factory, or performed between different factories such as an source material manufacturing factory and a pharmaceutical preparation manufacturing factory. In order to be prepared for a next process after one process is finished in each unit operation, a used tank, line, and the like are washed.
Washing is required to be completely performed, and since confirmation of complete washing is also included in the process, enormous effort and labor are required.
In recent years, for the purpose of avoiding washing that requires effort and labor, a technique of using a disposable flexible container instead of a tank or the like that is required to be washed has been developed, and particularly, such a trend has developed mainly in the bio-pharmaceutical product manufacturing industry. To be specific, a bag with a port member in which the port member that can be connected to a connection port of an existing facility such as a stainless steel tank is attached to an opening of a flexible bag has been used.
Such bags with a port member are disclosed in the following Patent Documents 1 and 2.
The bag with a port member disclosed in Patent Document 1 includes a flexible bag, a port member having a cylindrical part inserted into the bag from an opening of the bag, and a clamp that clamps the opening portion of the bag over the outer circumferential face of the cylindrical part inserted into the bag.
In addition, the bag with a port member disclosed in Patent Document 2 includes a flexible bag, and a port member having a cylindrical part inserted into the bag from an opening of the bag. The port member is attached to the bag in such a way that the outer circumferential face of the cylindrical part inserted into the bag adheres to the inner circumferential face of the opening portion of the bag.